Events

Rappel de BUR - CARBIDE FLUTED BALL

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par THE ANSPACH EFFORT INC..

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    41708
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2014-01-13
  • Pays de l'événement
    Canada
  • Source de l'événement
    HC
  • Notes / Alertes
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Notes supplémentaires dans les données
  • Cause
    The laser marking location is out of specification which causes it to align with the distal bearing of the attachment and can lead to a potential cutting burr fracture.

Device

BUR - CARBIDE FLUTED BALL
  • Modèle / numéro de série
    Model Catalog: S-5B-C (Lot serial: CONTACT MANUFACTURER); Model Catalog: S-4BL-C (Lot serial: CONTACT MANUFACTURER); Model Catalog: S-4B-C (Lot serial: CONTACT MANUFACTURER); Model Catalog: S-3B-C (Lot serial: CONTACT MANUFACTURER); Model Catalog: S-2B-C (Lot serial: CONTACT MANUFACTURER); Model Catalog: S-6B-C (Lot serial: >10 NUMBERS); Model Catalog: S-5B-C (Lot serial: >10 NUMBERS); Model Catalog: S-4BL-C (Lot serial: >10 NUMBERS); Model Catalog: S-4B-C (Lot serial: >10 NUMBERS); Model Catalog: S-3B-C (Lot serial: >10 NUMBERS); Model Catalog: S-2B-C (Lot serial: >10 NUMBERS); Model Catalog: S-6B-C (Lot serial: G023074168); Model Catalog: S-5B-C (Lot serial: G023074168); Model Catalog: S-4BL-C (Lot serial: G023074168); Model Catalog: S-4B-C (Lot serial: G023074168); Model Catalog: S-3B-C (Lot serial: G023074168); Model Catalog: S-2B-C (Lot serial: G023074168); Model Catalog: S-2SB-C (Lot serial: E193049913); Model Catalog: S-3SB-C (Lot serial: E193049913); Model Catalog: S-2SB-C (Lot serial: C433027411); M
  • Description du dispositif
    BUR - CARBIDE FLUTED BALL
  • Manufacturer
    THE ANSPACH EFFORT INC.

Manufacturer

THE ANSPACH EFFORT INC.
  • Adresse du fabricant
    PALM BEACH GARDENS
  • Société-mère du fabricant (2017)
    Johnson & Johnson
  • Source
    HC